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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Detail

Product Description Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
Recall Number D-1703-2012
Classification Class III
Code Info Lot: 3018952, Exp 08/12
Product Distributed Qty 31,867 Bottles
Reason For Recall Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.

Event Detail

Event Id 62911
Product Type Drugs
Status Ongoing
Recalling Firm Mylan Pharmaceuticals Inc.
City Morgantown
State WV
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and PR